MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A28-28/C95-O20

Device Problems Stretched (1601); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

Based on the clinical assessment for this event, the reported type iiia endoleak with component separation was found to be a type iiib endoleak and stent graft dilation of the both the cuff and main body.The most likely cause of the compromised stent graft integrity was found to be unknown/undetermined due to the lack of medical information surrounding the event, however, the severe angulation of the components likely contributed to the failures.Procedure, user, or anatomy related issues, and/or off-label and cautionary product use conditions could not be determined.The patient disposition is doing well after the re-intervention.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b endoleak events; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.The type 3b endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type 3b endoleak events reported for afx devices has been reduced to <0.2%.

Event Description

An afx system was used to treat a patient with an abdominal aortic aneurysm.Approximately 4 years post-op, a type 3a endoloeak was reported.Upon clinical assessment for the reported event, it was found that the reported type iiia endoleak with component separation was found to be a type iiib endoleak and stent dilation of both the bifurcated main body and the cuff.This report is the for the cuff.(main body reported under 2031527-2017-00385).

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 6952019
• MDR Text Key: 89406397
• Report Number: 2031527-2017-00528
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2015
• Device Model Number: A28-28/C95-O20
• Device Lot Number: 1026380-023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2017
• Initial Date FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BIFURCATED STENT GRAFTLOT#: W11-3564R-014
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR